Kornimate/medical-research-clean huggingface dataset:
comparison of two robotic-assisted total knee arthroplasty systems

Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Disease

Summary: the goal of this prospective study is to compare two different knee replacement robots. this study will look at patient reported outcome measures and data collected during the operation. the main questions this study aims to answer include: * will the patient reported outcomes differ between the two groups? * will the intraoperative data differ between the two groups? participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.

the purpose of this study is to compare two different total knee arthroplasty (tka) robotic assisted (ra) devices. this study will compare patient reported outcome measures prior to and after surgery. these surveys will be used determine if there are differences in patient recovery after tka depending on the robot used. radiographs will also be taken and used to compare component positioning. intraoperative data will be collected to compare or efficiency of the two systems.

Eligibility criteria:
inclusion criteria: * patient must be a candidate for primary tka (either stryker triathlon with mako robotic-arm or depuy attune with velys robotic-assistance). * individuals who are able to speak, read, and comprehend the institutional review board approved informed consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the sponsor. * individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol. * individuals who are male or non-pregnant female age 18-80 years at time of device implantation. * patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee. exclusion criteria: * patient has a body mass index (bmi) \> 40. * patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator. * patient has an active or suspected latent infection in affected knee joint. patient has neuromuscular or neurosensory deficiency. * patient is diagnosed with systemic disease or metabolic disorder (e.g., lupus, charcot's. paget's). * subject is a woman who is pregnant or lactating. * patient has a contralateral amputation. * patient's affected knee has a flexion contracture greater than 15 degrees. * patient has history of post operative arthrofibrosis. * patient's affected knee has a partial knee arthroplasty. * patient has undergone contralateral tka within the last three months. * patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims. * patient who is bedridden per the discretion of the investigator. * patient has a medical condition with less than 2 years of life expectancy.

Keywords: robotic assistance arthroplasty tka
dynamic monitoring of circulating microrna changes in patients with or without multiple organ failure

Conditions: Multiple Organ Failure

Summary: the objectives are to: 1. validate a panel of tissue-specific mirnas that are differentially expressed in the plasma of patients with and without multiple organ failure. 2. investigate the dysregulation of circulating mirna panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and multiple organ failure. this trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. the investigators will develop panels of mirnas that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these mirnas.

the icu patients with multiple organ failure in sponsor's institutes will be enrolled in this observational cohort of investigation. whole blood samples will be separated immediately into plasma for storage. the participants will have their 2nd and 3rd samples obtained at 24-48 hours and 48-72 hours respectively. the schedule of most of sampling schedule is designed in concordance with the icu routines to avoid extra burdens on patients. the plasma samples will be used as prognostic markers in prognostic and predictive values in identifying patients at high risk for mortality and multiple organ failure. patients who are discharged will be tracked for any clinical recurrence of the diseases every 28 days to assess the diagnostic accuracy of the mirna biomarkers that are measured. the 2nd objective will be assessed by measuring the concentration of mirnas in normal patients without multiple organ failure. the circulating mirnas will be detected directly from 1 - 5 ul of plasma samples with the mirflp assay. this capillary electrophoresis-based mirna quantification method detects multiple mirnas in absolute copy number in smaller sample signature with negligible batch to batch variation, thus providing a standard mirna detection method.

Eligibility criteria:
inclusion criteria for subjects: * adults 18 years and above * has condition related to icu enrollment cause exclusion criteria for subjects: * age below 18 years * known pregnancy * treating physician deems aggressive care unsuitable * unable to provide informed consent or comply with study requirements inclusion criteria for normal controls: • adults 18 years and above exclusion criteria for normal controls: * underlying chronic inflammatory condition (e.g. inflammatory bowel disease) * underlying autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus) * pre-existent liver disorder * user of any prescript medicine or over the counter drugs in prior 7 days.

Keywords: microrna
zd6474 (zactima™) phase iii study in egfr failures

Conditions: Non-Small-Cell Lung Carcinoma

Summary: this study is being carried out to assess if adding zd6474 to best supportive care (bsc) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an epidermal growth factor receptor tyrosine kinase inhibitor (egfr tki). zd6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. it targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. early studies indicate that zd6474 has a positive effect on the time that a tumour may take to progress to a further stage. approximately 930 patients will take part in this study. it will be conducted in hospitals and clinics in north and south america, europe and asia.


Eligibility criteria:
inclusion criteria: * patients with non-small cell lung cancer for which the standard cancer treatments of surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate treatments for you. exclusion criteria: * patients who have had standard cancer treatments of surgery, chemotherapy or other systemic anti-cancer therapy within 4 weeks before start of study therapy. * three or more prior chemotherapy regimens. * significant cardiovascular events.

Keywords: non-small-cell lung carcinoma adenocarcinoma squamous cell carcinoma large cell carcinoma
evaluation of the heidelberg engineering spectralis with flex module for in-vivo imaging in the supine position

Conditions: Retinal Disease; Healthy Eyes

Summary: this is a prospective clinical study conducted at one clinical site in the united states.

the conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.

Eligibility criteria:
adult normal eyes population (an) inclusion criteria for an population 1. age ≥ 22 years 2. able and willing to undergo the test procedures, sign informed consent, and follow instructions. 3. physically able to be positioned in all required imaging positions (upright at chinrest and supine). 4. able to fixate. 5. best corrected visual acuity ≥ 20/40 in both eyes. exclusion criteria for an population 1. eye with ocular media not sufficiently clear to obtain acceptable study-related imaging. 2. subjects who cannot tolerate the imaging procedures. 3. clinically significant ocular disease in either eye as determined by an investigator. 4. ocular surgical intervention (except for refractive laser surgery or cataract surgery) in either eye. adult posterior segment abnormality eye population (ad) inclusion criteria for ad population 1. age ≥ 22 years 2. able and willing to undergo the test procedures, sign informed consent, and follow instructions. 3. physically able to be positioned in all required imaging positions (upright at chinrest and supine). 4. able to fixate. 5. eye with a structural and vascular posterior segment abnormality due to ocular disease and/or trauma. exclusion criteria for ad population 1. eye with ocular media not sufficiently clear to obtain acceptable study-related imaging. 2. subjects who cannot tolerate the imaging procedures.
investigation of lbx1, timp2, gpr126 and chd7 gene polymorphisms in adolescent idiopathic scoliosis patients

Conditions: Adolescent Idiopathic Scoliosis; Single Nucleotide Polymorphisms

Summary: adolescent idiopathic scoliosis (ais) is a common disease of the spine observed in individuals aged 10-18 who typically do not have any other health issues. despite numerous genetic studies conducted across different ethnic groups worldwide, the specific genes contributing to the development of scoliosis have not yet been definitively identified. therefore, the aim of our study is to investigate whether there is an etiological relationship between ais and the polymorphisms of the lbx1 (rs11190870, rs625039, rs11598564), timp2 (rs8179090), gpr126 (rs6570507), and chd7 (rs121434341) genes in the turkish population and to determine the relationship of these polymorphisms with gender, age, age at diagnosis and cobb angle in these patients.

this prospective genetic research was conducted bursa uludag university faculty of medicine, department of orthopedics and traumatology. a total of 301 individuals were included in the study, comprising 201 patients aged 10-18 years diagnosed with ais and cobb angle of 10 degrees or more on direct radiography, no known genetic disorders and no diseases known to play a role in the etiology of scoliosis and 100 healthy controls aged 10-18 years without a diagnosis of scoliosis based on physical examination and/or imaging. in the study, the lbx1, timp2, gpr126 and chd7 gene polymorphisms in ais patients and the control group were analyzed using real-time pcr with taqman probe snp (single nucleotide polymorphism) primers (rs625039, rs11598564, rs6570507, rs121434341, rs11190870, rs8179090). subsequently, the snp regions were confirmed by dna sequence analysis. the obtained findings were statistically analyzed.

Eligibility criteria:
inclusion criteria: study group * being diagnosed with adolescent idiopathic scoliosis (ais) between the ages of 10 and 18. * having a cobb angle of 10 degrees or greater on a plain radiograph. * not having any known genetic disorders. * not having any diseases known to play a role in the etiology of scoliosis (degenerative, neuromuscular, congenital scoliosis, etc., are excluded). control group * healthy individuals who have not been diagnosed with scoliosis by physical examination and/or imaging. * being between the ages of 10-18 exclusion criteria: study group * those diagnosed with non-idiopathic scoliosis. * individuals who develop scoliosis after the age of 18. * individuals with scoliosis under the age of 10. * those diagnosed with a genetic disease. * those diagnosed with any disease known to play a role in the etiology of scoliosis. control group * those who have physical examination suspicion of scoliosis. * those with a cobb angle of 10 degrees or more on plain radiographs.

Keywords: adolescent idiopathic scoliosis genetic single nucleotide polymorphism
combination chemotherapy followed by radiation therapy in treating children with localized ependymoma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. purpose: this phase ii trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.

objectives: * determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy. * determine the response rate in these patients to this regimen. outline: this is a multicenter study. patients undergo surgery to remove as much of tumor as possible. patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy. chemotherapy begins within 3 weeks of surgery and consists of vincristine iv on days 1, 8, and 15, cyclophosphamide iv over 3 hours on day 1, and etoposide iv over 4 hours on days 1-3. treatment repeats every 4 weeks for up to 4 courses. patients who progress after 2 courses proceed to radiotherapy. if residual disease is still present at completion of chemotherapy, second look surgery is recommended. patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery. patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years. projected accrual: a total of 65 patients will be accrued for this study within 2-3 years.

Eligibility criteria:
disease characteristics: * histologically proven nonmetastatic intracranial ependymoma * cellular * papillary * clear cell * mixed cell * anaplastic * no myxopapillary ependymoma, subependymoma, or ependymoblastoma patient characteristics: age: * 3 to 20 performance status: * not specified life expectancy: * not specified hematopoietic: * no hematologic disease that would preclude study participation hepatic: * not specified renal: * no renal disease that would preclude study participation other: * no concurrent unrelated disease that would preclude study participation prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * prior steroids allowed radiotherapy: * no prior radiotherapy surgery: * not specified

Keywords: childhood infratentorial ependymoma childhood supratentorial ependymoma newly diagnosed childhood ependymoma
outcomes of compliance with brace wear in clubfoot

Conditions: Clubfoot

Summary: it has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. these studies have depended on family logs and not objective data. with the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes. hypothesis: actual patient compliance in foot abduction orthoses (fao) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.

it is necessary that treatment teams avoid making any assumptions about patient compliance. this study will objectively measure brace wear-rate in patients with clubfoot that have already been prescribed a foot ankle orthosis. the use of a monitoring device will be able to give objective data on actual patient compliance with brace wear. it is hypothesized that objective compliance data will allow physicians to better assess the patient's therapy progress and outcome, troubleshoot problems or issues associated with barriers to brace wear, and better educate families confronted with having a child with clubfoot. long term goals will then attempt to determine whether certain brace designs can increase wear time thus decreasing the rate of clubfoot recurrence.

Eligibility criteria:
inclusion criteria: * unilateral or bilateral clubfoot * birth to 3 years of age * has been successfully treated with ponseti casting protocol exclusion criteria: * any other prior treatment for clubfoot * other existing diagnoses or conditions

Keywords: clubfoot compliance brace wear
cost-effectiveness of isbcs vs. dsbcs

Conditions: Bilateral Cataract

Summary: the purpose of this study is to evaluate the effectiveness and costs of immediately sequential bilateral cataract surgery (isbcs) compared to delayed sequential bilateral cataract surgery (dsbcs) in order to determine whether isbcs is an effective and cost-effective alternative to dsbcs.

with an estimated number of 180,000 cataract extractions per year in the netherlands, cataract surgery is one of the most frequently performed types of surgery. the majority of patients suffer from bilateral cataract and while cataract surgery of one eye is effective in restoring functional vision, second-eye surgery leads to further improvement in health-related quality of life. currently, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (dsbcs). an alternative procedure involves cataract surgery of both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (isbcs). potential benefits of isbcs include less time between surgeries, a faster total recovery period and lower costs. potential risks, however, are complications of cataract surgery in general, most importantly the risk of endophthalmitis and refractive surprise. in isbcs, both eyes are at risk at the same time, while in dsbcs both eyes are exposed to these risks consecutively. since there is no consensus yet about the role of isbcs in current regular practice, further investigation of functional and surgical outcomes and cost-effectiveness of isbcs compared to dsbcs is required. therefore, the purpose of this study is to evaluate the effectiveness and costs of isbcs compared to dsbcs, in order to determine whether isbcs is an effective and cost-effective alternative to dsbcs.

Eligibility criteria:
inclusion criteria: * bilateral cataract * indication for bilateral cataract surgery * expected uncomplicated surgery exclusion criteria: * inability to comply with study procedures or to complete follow-up / dutch questionnaires. * non-routine cataract surgery * cognitive or behavioural conditions that might interfere with surgery * cataract surgery with premium iol implantation * conditions that increase the risk of endophthalmitis (e.g. current ocular/adnexal/periocular infections, immune-compromised, iodine allergy) * factors that increase the risk of refractive surprise (e.g. axial lengths \ 27mm, difference between eyes of \>1.5mm, abnormal keratometry readings, previous refractive surgery) * conditions that increase the risk of corneal edema * factors that increase the risk of complicated surgery (e.g. previous surgery, trauma, anatomical abnormalities) * sight-threatening comorbidity, glaucoma or iop \> 24mmhg, uveitis, diabetes with diabetic retinopathy and macular edema
outcome of balloon pulmonary valvuloplasty in patients with congenital pulmonary stenosis in terms of reverse right ventricular remodelling and functional exercise capacity

Conditions: Congenital Heart Disease; Pulmonary Valve Stenoses

Summary: a prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to 1. - evaluate electrical and mechanical remodeling of rv 6 months following balloon dilation 2. - evaluate functional capacity using 6mwt and sao2 before and 6 months following bpv

valvular pulmonary stenosis (ps), defined as an obstruction of blood flow at the level of the pulmonary valve, is a form of congenital heart disease, described in 0.6-0.8 out of 1000 live births. the main physiologic effect of valvular pulmonary stenosis (ps) is an increase in right ventricular pressure proportional to the severity of obstruction. this elevation of rv pressure is accompanied by an increase in muscle mass where hyperplasia of the muscle cells with a concomitant increase in the number of capillaries occurs. in contrast, the adult myocardium responds with hypertrophy of the existing fibers, with no change in the capillary network. percutaneous balloon pulmonary valvuloplasty (pbpv) is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. the aim is to 1. - evaluate electrical and mechanical remodeling of rv 6 months following balloon dilation 2. - evaluate functional capacity using 6mwt and sao2 before and 6 months following bpv

Eligibility criteria:
inclusion criteria: * 1-adult population with an age more than or equal to 16 years of age at time of procedure 2-severe valvular pulmonary stenosis defined as a pg max more than or equal to 64 mmhg measured by 2d echo before procedure exclusion criteria: 1. patients with isolated supra-valvular and sub valvular pulmonary stenosis 2. patients with peripheral pulmonary stenosis. 3. patients with pulmonary stenosis if part of another congenital heart disease . 4. patients with organically diseased tricuspid valve 5. patients with any significant shunt lesion which result in dilation in rv such as atrial septal defect. 6. patients with right ventricular dysfunction due to arrhythmogenic right ventricular dysplasia (arvd) or non compaction